宾大医学健康心脏项目的设计与原理：一项针对动脉粥样硬化性心血管疾病高危患者改善血压和胆固醇的集中组织方法有效性的随机试验。

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal Pub Date : 2024-09-27 DOI:10.1016/j.ahj.2024.09.029

K.G. Volpp MD, PhD , K. Mahraj MSI , L.A. Norton MA, MBE , D.A. Asch MD, MBA , K. Glanz PhD, MPH , S.J. Mehta MD, MBA , M. Balasta MD , W. Kellum MD , J. Wood MD , L.B. Russell PhD , A.C. Fanaroff MD , S. Bakshi MD , D. Jacoby MD , J.B. Cohen MD, MSCE , M.J. Press MD , K. Clark MPH , J. Zhu MS, MBA , C. Rareside MS , L.E. Ashcraft PhD , C. Snider MPH , M.E. Putt PhD

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引用次数: 0

摘要

理由：动脉粥样硬化性心血管疾病（ASCVD）是美国发病率和死亡率的主要原因。高血压和高脂血症控制不佳是导致动脉粥样硬化性心血管疾病风险的常见因素。宾大医学健康心脏（PMHH）研究是一项随机临床试验，目的是测试一个系统的有效性，该系统旨在通过使用一个由非临床导航员和高级医疗服务提供者组成的集中团队、远程监控、双向短信以及行为科学参与策略来减轻初级保健临床医生的工作量，并改善患者对降低风险策略的跟踪。该干预措施建立在之前对这些设计元素进行的非随机评估的基础上，这些评估显示患者的收缩压和低密度脂蛋白胆固醇（LDL-C）得到了显著改善：主要假设：在为期 6 个月的干预过程中，与常规护理相比，宾大医学健康心脏项目将明显改善收缩压和低密度脂蛋白胆固醇：设计：在收缩压和低密度脂蛋白胆固醇（LDL-C）控制不佳的 35-80 岁 ASCVD 高危患者中开展宾大医学健康心脏随机临床试验。干预措施包括四个模块，分别涉及血压管理、血脂管理、营养和戒烟，分阶段进行，以便参与者有时间了解每个主题、采纳任何建议并与护理团队建立关系：地点：宾夕法尼亚大学卫生系统位于市内城区和农村/半农村地区的初级保健诊所：收缩压和低密度脂蛋白胆固醇的改善：计划进行成本效益分析，以评估干预方法的医疗成本和健康结果。计划进行一项实施评估，以了解影响干预成功的因素。预计入组人数：宾夕法尼亚大学医学院初级保健实践中的 2420 名活跃患者，这些患者患有临床 ASCVD 或 ASCVD 风险较高，并且 (a) 未服用他汀类药物或尽管服用他汀类药物但 LDL-C > 100，以及 (b) 在最近两次门诊就诊时收缩压>140：入组日期：2024 年 3 月至 2025 年 3 月。干预将持续 6 个月，随访 12 个月，以确定其效果是否持续：临床试验注册：NCT06062394。

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Design and rationale of penn medicine healthy heart, a randomized trial of effectiveness of a centrally organized approach to blood pressure and cholesterol improvement among patients at elevated risk of atherosclerotic cardiovascular disease

Rationales

Atherosclerotic Cardiovascular Disease (ASCVD) is the leading cause of morbidity and mortality in the United States. Suboptimal control of hypertension and hyperlipidemia are common factors contributing to ASCVD risk. The Penn Medicine Healthy Heart (PMHH) Study is a randomized clinical trial testing the effectiveness of a system designed to offload work from primary care clinicians and improve patient follow-through with risk reduction strategies by using a centralized team of nonclinical navigators and advanced practice providers, remote monitoring, and bi-directional text messaging, augmented by behavioral science engagement strategies. The intervention builds on prior nonrandomized evaluations of these design elements that demonstrated significant improvement in patients’ systolic blood pressure and LDL Cholesterol (LDL-C).

Primary Hypothesis

Penn Medicine Healthy Heart will significantly improve systolic blood pressure and LDL-C compared to usual care over the 6 months of this intervention.

Design

Randomized clinical trial of Penn Medicine Healthy Heart in patients aged 35-80 years at elevated risk of ASCVD whose systolic blood pressure and LDL-C are not well controlled. The intervention consists of 4 modules that address blood pressure management, lipid management, nutrition, and smoking cessation, offered in a phased approach to give the participant time to learn about each topic, adopt any recommendations, and build a relationship with the care team.

Sites

University of Pennsylvania Health System at primary care practices located in inner-city urban and rural/semi-rural areas.

Primary Outcomes

Improvement in systolic blood pressure and LDL-C.

Secondary Outcomes

Cost-effectiveness analyses are planned to evaluate the health care costs and health outcomes of the intervention approach. An implementation evaluation is planned to understand factors influencing success of the intervention.

Estimated Enrollment

2,420 active patients of Penn Medicine primary care practices who have clinical ASCVD, or who are at elevated risk for ASCVD, and who are (a) not on statins or have LDL-C >100 despite being on statins and (b) had systolic blood pressure >140 at 2 recent ambulatory visits.

Enrollment Dates

March 2024-March 2025. The intervention will last 6 months with a 12-month follow-up to determine whether its effects persist.

Current Status

Enrolling (1,240 enrolled as of August 15, 2024)

Clinical Trial Registration

NCT06062394

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来源期刊

American heart journal 医学-心血管系统

CiteScore

8.20

自引率

2.10%

发文量

214

审稿时长

38 days

期刊介绍： The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.